Manager – CRU Operations (1 Yr Contract)

PURPOSE OF THE JOB:

• Responsible for the operations of the Clinical Research Unit (CRU) and cross functional interactions within the CRU, working closely with Manager - Pharmacy Operations and Manager -Patient Recruitment.
• Leads and influences cross-functional communications to ensure smooth delivery of clinical studies.
• Provides project management and study execution leadership in the delivery of clinical studies.

CORE JOB TASK

CRU Operations

• Work closely with LCCP Management to align on the management of CRU’s study portfolio.
• Drives the integration of CRU cross-functional activities to deliver study requirements.
• Provides operational leadership to CRU study teams, through participation in various meetings such as protocol review meetings, study execution meetings and liaising with sponsor and CRO team to resolve emerging study execution issues.
• Provides consistency in study execution in the CRU by:
• Serving as Subject Matter Expert and a resource of knowledge for CRU operational processes, local IRB and regulatory requirements.
• Providing input on study design and operational feasibility during study planning.
• Working with sponsor and site project teams to ensure consistency in responses to IRB.
• Working with scheduler and project specialist to ensure development of realistic project milestones and deliverables.
• Influences study teams to maintain proper documentation of key decisions, actions and meeting minutes.
• Identify and share learning opportunities or process improvements with teams to improve effectiveness of study execution.
• Work with cross functional teams in root cause analysis and identification of appropriate corrective and preventive actions (CAPAs). Perform post implementation assessment to ensure CAPAs are effectively implemented.
• Provides input and ensures cross functional alignment in response to feasibility, RFI and RFP. Flag any CRU capability gaps that are identified during the RFI/RFP process and work with Management to develop a remediation plan.
• Maintains a database of clinical operational information relevant to the CRU.
• Oversee equipment life cycle management to ensure equipment are maintained to support CRU capabilities. Assume System Owner role where appropriate.
• Oversees IRB submissions and ensure submission timelines are adhered to.
• Ensure remedial initiatives are being carried out to address any quality issues identified during the quarterly quality governance meeting.
• Review CRU Standard Operating Procedures (SOPs) to ensure cross alignment and the SOPs remain current and appropriate.

Project Oversight and Project Management

• Leads and oversees CRU implementation of Lilly’s high priority clinical studies to ensure deliverables are met to support Lilly’s global portfolio decisions.
• Leads and oversees non-clinical projects that has moderate risk and moderate to high impact on the operational functioning and capability of the CRU in delivering clinical studies.

Regulatory Compliance

• Ensures studies are carried out in accordance to approved protocol, IRB & regulatory requirements, Good Clinical Practice (GCP), Lilly global policies and local SOPs.
• Ensures personal and team’s compliance to required training.
• Maintains awareness of local and (where relevant) global regulatory requirements to ensure operational compliance.

Audits, Inspections and Self-Assessments

• Performs and/or supports self-assessments activities.
• Participates actively in all GQAAC audits and external regulatory inspections.

People Management

• Attracts, retains and develops a diverse workforce.
• Supervises, coaches and manages team members to effectively deliver results for the CRU.
• Defines individual and functional group objectives in alignment with LCCP priorities and Lilly objectives.
• Manages team members’ performance through the performance review process.

Required Qualifications and Experience

• Degree in science or health-related field.
• Minimum 10 years of experience in clinical research with clinical operations and/or project management experience.
• Experience in early phase clinical research preferred.

Required Skills

• Ability to communicate with and influence cross functional teams.
• Excellent interpersonal and communication skills.
• Demonstrates effective problem-solving skills to influence result-oriented actions.
• Demonstrates strategic thinking and ability to think differently to incorporate new learning.
• Ability to influence business decisions.
• Understanding of clinical trial processes and the interdependencies of various tasks that require coordination across various functional teams.

Other Information

• Occasional travel to the USA may be required.
• Occasional out of office hour conference calls and meetings may be required.